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Search / Trial NCT06273046

Treatment of Fecal Incontinence and Functional Evacuation Disorders Using Non-instrumental Biofeedback

Launched by HOSPITAL UNIVERSITARI VALL D'HEBRON RESEARCH INSTITUTE · Feb 15, 2024

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people who suffer from fecal incontinence and certain types of constipation. Instead of the traditional method that requires special equipment and multiple sessions, this trial explores the use of simple, home-based exercises guided by videos. The goal is to see if these non-instrumental biofeedback techniques can help improve bowel control and function.

To participate, you should be experiencing at least four episodes of fecal incontinence in the last two weeks or have constipation with fewer than three bowel movements a week. Participants will be randomly assigned to either the biofeedback group, where they will learn and practice exercises at home, or a placebo group, where they will take a daily sugar pill. Throughout the study, you’ll attend a few check-in visits to see how well the treatment is working. This trial is currently recruiting participants of all genders, aged between 18 and 80, as long as they meet the eligibility criteria and do not have certain pre-existing health conditions.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Incontinence studies
  • Patients who have at least 4 episodes of fecal incontinence during the last 14 days.
  • Patients able to follow instructions and attend study visits.
  • Dyssinergic defecation studies
  • Patients with constipation who present less than 3 complete spontaneous bowel movements per week and/or who have Bristol 1 or Bristol 2 type stools in more than 25% of the bowel movements in the 2 weeks prior to the study
  • Patients able to follow instructions and attend study visits.
  • Exclusion Criteria:
  • Patients with organic digestive diseases such as inflammatory bowel disease, celiac disease, gastro-duodenal ulcer...
  • Patients with neurological diseases (spinal cord injury, multiple sclerosis, Parkinson's disease).
  • Patients with previous of active colon and/or rectal cancer.
  • Patients with rectal fistula.
  • Patients with rectal prolapse.
  • Patients with total colectomy.
  • Patients who have had any radiation to the pelvis in the last month.

About Hospital Universitari Vall D'hebron Research Institute

The Hospital Universitari Vall d'Hebron Research Institute (VHIR) is a leading biomedical research center affiliated with Vall d'Hebron University Hospital in Barcelona, Spain. Committed to advancing healthcare through innovative research, VHIR focuses on translating scientific discoveries into clinical applications, enhancing patient care and outcomes. The institute fosters collaboration among multidisciplinary teams of researchers, clinicians, and industry partners, emphasizing excellence in translational medicine, clinical trials, and public health initiatives. With a strong emphasis on ethical standards and patient safety, VHIR is dedicated to contributing to the global body of knowledge in various medical fields.

Locations

Barcelona, , Spain

Patients applied

0 patients applied

Trial Officials

Jordi Serra, MD

Principal Investigator

University Hospital Vall d'Hebron

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported